Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of lanreotide versus placebo for treatment of patients with digestive fistulae

Conditions: Digestive Fistulae

Summary: the purpose of the protocol, is to determine whether lanreotide 30 mg is effective in the treatment of patients with digestive fistulae.

the purpose of this study is to determine whether lanreotide 30mg compared to placebo is effective on the evolution of drainage volume of digestive fistulae in the 72 hours following the beginning of treatment and on the spontaneous closure time of digestive fistulae.

Eligibility criteria:
inclusion criteria: * patient with pancreatic, duodenal, or small intestine fistula * patient with simple, externalised fistula * patient with fistula for which a medical conservative treatment is considered * patient with: * for pancreatic fistulae: a mean drainage volume more than or equal to 100 ml/24h over 48 hours or more than or equal to 50 ml / 24h over 3 days and a concentration of amylase in the drainage fluid 3 times higher than in the serum over at least 2 or 3 consecutive days respectively, * for duodenal and small intestine fistulae: a mean drainage volume more than or equal to 100ml/24h over 2 days exclusion criteria: * patient expected to require a surgical treatment of the fistula during the study * patient having uncontrolled intra-abdominal sepsis; crohn's disease; radiotherapy lesions of the small bowel; a mesenteric vascular insufficiency; a fistula localised in cancer-infiltrated areas; a distal obstruction; an exposed fistula of the small intestine; or intra-abdominal foreign bodies. * patient receiving long-term corticotherapy * patient having received any somatostatin analogue as curative treatment of the fistula or any prf somatostatin analogue within the previous month. * patient having previously undergone a transplant

Keywords: treatment
evaluation of the animated cartoon-aided teaching of intranasal corticosteroid allergic rhinitis

Conditions: Asthma; Allergic Rhinitis

Summary: correct methods and compliance of intranasal corticosteroid (incs) is very important for the treatment of allergic rhinitis (ar). the animated cartoon-aided teaching of incs administration was created to decrease workload of health care professionals. the aim of this study is to compare the achievement of the children with ar in using incs between the group which were instructed by animated cartoon-aided teaching or oral presentation without demonstration.

the study was a prospective randomized control trial in children aged 5 - 16 years with moderate to severe intermittent or persistent ar who had never used incs. the patients were randomly divided into 2 groups; 1) teaching how to use incs by oral presentation and 2) by animated cartoon-aided teaching. successful achievements were recorded when the patients were able to use incs (all five-point checklists) correctly. if they were unable to use the incs correctly after the first teaching, the same instruction would be repeated and the second assessment would be performed.

Eligibility criteria:
inclusion criteria: * children with 5 - 16 year old * children with allergic rhinitis exclusion criteria: * history of intranasal corticosteroid use * history of other underlying disease

Keywords: animated cartoon-aided teaching oral presentation allergic rhinitis intranasal corticosteroid how to use intranasal corticosteroid
reduce lap-hf trial

Conditions: Heart Failure

Summary: the objective of this clinical study is to evaluate the safety and performance of the iasd system ii in the treatment of heart failure patients with elevated left atrial pressure, who remain symptomatic despite appropriate medical management.


Eligibility criteria:
key inclusion criteria: 1. chronic symptomatic heart failure (hf) documented by one or more of the following: 1. new york heart association (nyha) class ii/iii/ambulatory class iv symptoms (paroxysmal nocturnal dyspnea, orthopnea, dyspnea on mild or moderate exertion) at screening visit; or signs (any rales post cough, chest x-ray demonstrating pulmonary congestion,) within past 12 months; 2. one hospital admission for which hf was a major component of the hospitalization within the 12 months prior to study entry (transient heart failure in the context of myocardial infarction does not qualify); 3. on-going management with recommended heart failure medications and comorbidities for several months according to the guidelines (2012 esc guidelines for diagnosis and treatment of acute and chronic heart failure). 2. age ≥ 40 years old 3. left ventricular ejection fraction (obtained by echocardiography) ≥ 40% 4. elevated left ventricular filling pressures with a gradient compared to cvp documented by : 1. pcwp or lvedp at rest ≥ 15 mmhg, and greater than cvp, or 2. pcwp during supine bike exercise ≥ 25mm hg, and cvp \< 20 mm hg key exclusion criteria: 3. severe heart failure defined as: 1. acc/aha/esc stage d heart failure, non-ambulatory nyha class iv hf; 2. fick cardiac index \< 2.0 l/min/m2 3. requiring inotropic infusion (continuous or intermittent) within the past 6 months 4. patient is on the cardiac transplant waiting list 4. inability to perform 6 minute walk test 5. known significant coronary artery disease (stenosis \>70%) 6. history of stroke, transient ischemic attack (tia), deep vein thrombosis (dvt), or pulmonary emboli within the past 6 months 7. known severe carotid artery stenosis (\> 70%) 8. presence of significant valve disease defined by echocardiography as: a) mitral valve regurgitation defined as grade \>2+ mr b) tricuspid valve regurgitation defined as grade ≥ 2+ tr; c) aortic valve disease defined as ≥ 2+ ar or moderate as
hypotonia and neurofibromatosis type 1 (nf1) glioma

Conditions: Neurofibromatosis Type 1

Summary: currently, optic pathway gliomas (opg) are detected based on abnormal findings made during annual ophthalmologic exams. however, because these exams are annual, it is possible for healthcare providers to miss the point at which a child's vision begins to decline (potentially indicating an opg). if at-risk children are screened for hypotonia early in life, those children who are hypotonic may undergo magnetic resonance imaging (mri) to evaluate for opg before they are showing ophthalmologic symptoms. this would enable healthcare providers to discover vision loss earlier and treat symptomatic opgs earlier, thereby allowing us a better chance of preventing further vision loss in children with opgs.


Eligibility criteria:
inclusion criteria: * patient must be seen at the st. louis children's hospital nf clinic * diagnosis of nf1 * between 1 and 7 years of age, inclusive * diagnosed with hypotonia * legally authorized representative/guardian must be able to understand and willing to sign an irb-approved informed consent document * must have an mri scan ordered by a treating physician exclusion criteria: * normal tone on clinical exam * known allergy to gadolinium or the sedative, propofol, used during mri * poor kidney function defined as a known renal disease or elevated bun and creatine * requiring intubation for anesthesia
an open-label, multicenter study evaluating the safety, efficacy, and pharmacokinetics of mosunetuzumab in combination with tiragolumab with or without atezolizumab in participants with b-cell non-hodgkin lymphoma

Conditions: Non-Hodgkin Lymphoma, Follicular Lymphoma

Summary: this study will evaluate the safety, efficacy, and pharmacokinetics of mosunetuzumab in combination with tiragolumab, with or without atezolizumab, in participants with relapsed or refractory (r/r) diffuse large b-cell lymphoma (dlbcl) or follicular lymphoma (fl) who have received at least two previous lines of systemic therapy.


Eligibility criteria:
inclusion criteria: * aged \>/= 18 years * eastern cooperative oncology group (ecog) performance status of 0, 1, or 2 * life expectancy of at least 12 weeks * histologically documented fl or dlbcl that has relapsed or failed to respond to at least two prior systemic treatment regimens and for which no suitable therapy of curative intent or higher priority exists (e.g., standard chemotherapy, asct, car t cells) * at least one bi-dimensionally measurable (\> 1.5 cm) nodal lesion, or at least one bi-dimensionally measurable (\> 1.0 cm) extranodal lesion * participants with fl (including trfl) for whom a bone marrow biopsy and aspirate can be collected * adequate hematologic and organ function exclusion criteria: * received any of the following treatments prior to study entry: mosunetuzumab or other cd20/cd3-directed bispecific antibodies; tiragolumab or other anti-tigit agent; allogenic sct; solid organ transplantation * currently eligible for autologous sct * current or past history of cns lymphoma or leptomeningeal infiltration * history of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibody therapy (or recombinant antibody-related fusion proteins) * contraindication to atezolizumab (if applicable) or tocilizumab * clinically significant toxicities from prior treatment have not resolved to grade \</= 1 (per nci ctcae v5.0) prior to the first study drug administration with exceptions defined by the protocol * treatment-emergent immune-mediated adverse events associated with prior immunotherapeutic agents as defined by the protocol * evidence of any significant, concomitant disease as defined by the protocol * major surgery within 4 weeks prior to first study treatment administration, with the exception of protocol-mandated procedures (e.g., tumor biopsies and bone marrow biopsies) * significant cardiac, pulmonary, cns, or liver disease, or known active infections * history of other malignancy that could affect compliance with the protocol or interpretation of results * history of autoimmune disease with exceptions as defined in the protocol

Keywords: b-cell non-hodgkin lymphoma
study to evaluate safety and efficacy of inhaled bimosiamose for the treatment of patients with moderate to severe chronic obstructive pulmonary disease (copd)

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the purpose of this study is to determine whether inhalation of bimosiamose is safe and effective in the treatment of patients with moderate to severe chronic obstructive pulmonary disease (copd)


Eligibility criteria:
inclusion criteria: * male and postmenopausal or sterile female patients with a history of moderate to severe copd defined as global initiative for chronic obstructive lung disease (gold) ii-iii for at least 1 year * at least 40 years of age * current smoker or ex-smoker with at least 10 pack-year smoking history (ten pack-years is defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20 years etc.) * postbronchodilator fev1 between 30% and 80% predicted and fev1/fvc ratio \< 70%. postbronchodilator refers to 30 min after inhalation of 400 µg salbutamol. this criterion for fev1 will have to be demonstrated after a washout period of at least 48 h during which no long acting anticholinergic medication (lama) or long acting β2-agonists (laba) has been inhaled or a washout period of 6 h during which no short acting β2-agonists (saba) or anticholinergic medication (sama) has been inhaled. for patients having been pretreated with an inhaled corticosteroid (ics) and/or theophylline, this criterion needs to be demonstrated after a washout of at least 4 weeks. * able to produce sputum upon induction in a sufficient quality. this criterion will be checked by the responsible sputum lab prior to randomization of the patient. * time and ability to complete the study * able to communicate well with the investigator, to understand and comply with the requirements of the study. understand and sign the written informed consent. exclusion criteria: * patients with a history of chronic respiratory disorders other than copd e.g. asthma, α1-antitrypsin deficiency, mucoviscidosis, lung fibrosis * patients who experienced an exacerbation in the 4 weeks before the screening visit or between screening and randomization * patients who experienced an acute upper respiratory tract infection or broncho-pulmonary infection requiring antibiotic treatment during the 4 weeks before the screening visit or between screening and randomization * treatment with inhaled (ics), topical or any systemic corticosteroids or theophylline within at least 4 weeks before the screening visit and throughout entire course of the study. patients with ics and/or theophylline treatment will undergo a washout of at least 4 weeks after signature of the informed consent and prior to the screening visit, where eligibility to enter the study will be assessed

Keywords: copd
a randomized controlled trial assessing the efficacy of lianhua qingwen as an adjuvant treatment in patients with mild symptoms of covid-19

Conditions: COVID-19

Summary: covid-19 virus remains in infected patients for extended periods of time. a great resource burden is placed on the healthcare system and society at large to isolate covid-19 patients for prolonged periods. thus, being able to increase the rate of viral clearance, thus reducing the duration of covid-19 infection, would allow patients to be discharged earlier to free up resources for those who require it. the investigators designed a randomized controlled trial, investigating the use of lianhua qingwen, a tcm treatment, in covid-19 infected patients with mild symptoms. the investigators hypothesize that the use of lianhua qingwen will increase the proportion of patients who test negative for covid-19 after 8 days of tcm treatment when compared to the group of patients provided with standard care and placebo. patients will be recruited from community isolation facilities, and have onset of symptoms within 5 days prior to admission to the isolation facility. the trial also evaluates the time taken for relief of clinical symptoms associated with covid-19 and assesses the safety of the tcm treatment given to patients.


Eligibility criteria:
inclusion criteria: 1. age ≥21 years 2. positive laboratory test for covid-19 by rt-pcr methods 3. presenting with at least one symptom (symptoms include fever, dry cough, sore throat, nasal congestion, malaise, headache, muscle pain, anosmia, and diarrhoea) 4. length of time between date of onset of symptoms and the date of recruitment should not exceed 5 days to ensure that trial participants are in the early stages of infection 5. no clinical or radiographic evidence of pneumonia 6. able to provide informed consent exclusion criteria: 1. individuals with underlying primary diseases such as cardiovascular, respiratory, liver, renal, diabetes, hepatitis a/b/c, gout or endocrinological diseases and neurological disorders which put them at a higher risk of developing severe disease 2. individuals with compromised immune systems such as malignant tumors, organ or bone marrow transplants, hiv, or have taken immunosuppressants in the past three months. 3. women who are pregnant or on lactation. 4. individuals with mental illness. 5. history of allergy to any drug or food, or herb ingredient observed in this trial. 6. individuals who are deemed not able to comply with trial procedure or follow-up

Keywords: covid-19 traditional chinese medicine randomized controlled trial lianhua qingwen
efficacy and safety of nipent, cytoxan and rituxan in the treatment of chronic lymphocytic leukemia.

Conditions: Chronic Lymphocytic Leukemia

Summary: this research study measures the safety and efficacy of the combination of three drugs that are approved, nipent, rituxan and cytoxan in the treatment of chronic lymphocytic leukemia (cll). these drugs are being given together for investigational purposes as the specific combination of these three drugs has not been approved for treatment of cll by the fda.

chronic lymphocytic leukemia (cll) is the most common form of adult leukemia in the u.s. recent experience with nipent in conjunction with rituxan has shown that this combination is well tolerated and is clinically promising. it is expected that the addition of cytoxan in patients with previously untreated cll and patients who have relapsed or failed prior therapy may benefit from combined therapy using nipent, cytoxan and rituxan. it is unknown how the addition of cytoxan will affect the toxicity profile of the rituxan and nipent regimen, however, patients will be monitored for toxicities. it is expected that bone marrow toxicities will not increase to unreasonable levels. the primary objective of the study is to determine the overall efficacy response rate following treatment with nipent, cytoxan and rituxan of patients with previously untreated or treated cll. the secondary objectives of the study are to determine the duration of response, time to progression, time to treatment failure and to evaluate the toxicity of this combination of drugs and the incidence and severity of adverse events.

Eligibility criteria:
inclusion criteria: * stage ii, iii or iv chronic lymphocytic leukemia * disease requires chemotherapeutic treatment * ct or mri scan confirming measurable tumor size * documentation of cd markers * up to one prior treatment regimen * expected survival greater than 6 months * ecog performance status of 0-2 * adequate renal, bone marrow and liver functions * negative pregnancy test (females of childbearing potential) * must agree to use acceptable birth control, if fertile * must complete informed consent * no heart disease and must have adequate cardiac function * must test negative for viral hepatitis b and c exclusion criteria: * more than one prior treatment for chronic lymphocytic leukemia * known sensitivity to nipent, rituxan or cytoxan or any component of these drugs * known hiv or aids illness * thyroid disease requiring medication * history of any malignancy that could affect the diagnosis or assessment of the study treatment * pregnancy or breast feeding * evidence of hepatitis b or c infection * inability to comply with the requirements of the study

Keywords: leukemia cancer nipent rituxan cytoxan
anatomopathological analysis and clinical evolution after radiological removal of retrievable vena cava filters

Conditions: Vena Cava Thrombosis

Summary: pulmonary embolism (pe) is a common pathology causing significant morbidity and mortality. it is usually secondary to migration through the inferior vena cava (ivc) of a formed thrombus in the veins of the lower limbs or pelvis. the inferior vena cava filter (ivcf) is a medical device whose purpose is to prevent thrombus migration from the veins of the legs and pelvis to the pulmonary arteries, thus preventing the occurrence of pulmonary embolism (pe). there is no data on the interactions of retrievable inferior vena cava filters (ivcf) with the inferior vena cava (intrafilter thrombi, insertion through the venous wall) although it may modify the evolution after ivcf retrievable.

the main objective of this study is to determine whether the presence of intrafilter thrombi identified by anatomopathology at the time of inferior vena cava filters (ivcf) retrievable was associated with the occurrence of a venous thromboembolism event within 3 months following removal.

Eligibility criteria:
inclusion criteria: * patients with a inferior vena cava filters (ivcf) placed because of temporary contraindication to curative anticoagulation and that was removed by the radiology department at the university hospital of saint-etienne exclusion criteria: * patients included in the prepic 2 study * patients whose basement filter had not been removed (difficult removal with surgery, no indication for removal).

Keywords: inferior vena cava filters mechanism retrievable deep venous thrombosis pathological evolution pulmonary embolism
genotype-phenotype correlations in patients with alport syndrome

Conditions: Alport Syndrome

Summary: alport syndrome (as) is caused by pathogenic variants in the type iv collagen genes col4a3, col4a4, and col4a5. this study aims to enroll families and patients with a history of renal hematuria in 27 hospitals and detect these three genes for as screening. this study also aims to analysis the effect of col4a3/col4a4/col4a5 genotype on the development of kidney disease.

alport syndrome (as) is a genetically and phenotypically heterogeneous disorder caused by the mutations in the type iv collagen genes col4a3, col4a4, and col4a5. in this study, next generation sequencing is used to screen as on 8165 participants enrolled from families and patients with a history of renal hematuria in 27 hospitals of china huadong region. genotype (variants in col4a3/col4a4/col4a5)-phenotype (onset age of hearing loss, nephroticrange proteinuria, decline of egfr, kidney survival and onset age of ckd5) correlations in as were evaluated.

Eligibility criteria:
inclusion criteria: 1. age: up to 99 years (child, adult, older adult) 2. sex: all; 3. families and patients with a history of renal hematuria; 4. those who signed the informed consent. exclusion criteria: 1. polycystic kidney disease, hypertensive nephropathy, etc.; 2. kidney biopsy is diagnosed as other primary/secondary kidney disease without type iv collagen-related kidney disease, including iga nephropathy, membranous nephropathy, lupus nephritis, etc. 3. incomplete medical history or clinical data.
sb-743921 in patients with solid tumors

Conditions: Solid Tumor Cancer

Summary: the purpose of this study is to find a dose of sb-743921 in adult patients with solid tumors or lymphoma who have progressed on standard therapy or who have relapsed. sb-743921 is dosed by 1-hour intravenous infusion every 3 weeks. a patient may continue to receive treatment as long as they are benefiting from the treatment. blood samples will be taken at specific times to measure the amount of the drug in your body at specific times after the drug is given. blood samples will also be taken for lab tests such as complete blood counts and clinical chemistries. physical exams will be performed before each treatment with sb-743921. during the treatment phase, the patients will undergo regular assessments for safety and clinical response.


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed diagnosis of: a) advanced solid tumor malignancy that is not responsive to standard therapies or for which there is no standard therapy; or b) b-cell or t-cell lymphoma (excluding hiv-associated lymphoma) that has relapsed or is refractory after prior chemotherapy or radiotherapy and autologous or allogeneic bone marrow transplantation (if appropriate) and/or for which salvage chemotherapy, radiotherapy, or bone marrow transplantation is not indicated or has been refused by the patient. * ecog (eastern cooperative oncology group) performance status of 0-2. exclusion criteria: * pre-existing hemolytic anemia. * pre-existing peripheral neuropathy greater than or equal grade 2. * absolute neutrophil count less than 1,500/mm3. * platelets less than 100,000/mm3. * hemoglobin less than 9 g/dl. * total bilirubin greater than1.5 mg/dl. * ast/alt greater than 2.5 x upper limit of normal. * creatinine clearance less than or equal to 60 ml/min.

Keywords: safety tolerability dose limiting toxicity solid tumors
pain perception by the chronic renal patient at the time of vascular access cannulation.

Conditions: Renal Dialysis

Summary: pain in patients under hemodialysis affects chronic renal patients' quality of life. distraction has been effective in controlling pain induced by the insertion of needles. once applied adequately, distraction promotes endorphins' release, with efficacy in acute pain. this study aims to evaluate pain perception while puncturing the hemodialysis device using an anti-stress ball as a distraction strategy.


Eligibility criteria:
inclusion criteria: * adults over 18 years old * able to read and write * vascular access by a fistula or arteriovenous prosthesis, cannulated with a 15g needle * vascular access at least with month old exclusion criteria: * patients under 18 years * can't be able to read and/or write * usage of topical anesthetics before treatment * vascular access by a fistula or arteriovenous prosthesis, cannulated with smaller or larger 15g needles * vascular access under one-month-old

Keywords: arteriovenous fistula renal insufficiency chronic quality of life distraction